LOTUS™ Introducer Set Indications, Safety and Warnings

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Lotus Introducer Set is intended to provide percutaneous femoral access to the vascular system.

CONTRAINDICATIONS

Severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.

WARNINGS:

  • Only those physicians who are trained in intravascular percutaneous procedures should use this device
  • After use, dispose of product and packaging in accordance with hospital administrative and/or local government policy

PRECAUTIONS:

Before using this device please note the following:

  1. The sterile package of the Lotus Introducer Set should be inspected prior to use. If sterility or integrity of the package is suspect or compromised, the product should not be used.
  2. All patients should receive antiplatelet and/or anticoagulant therapy appropriate to their condition at the discretion of their physician.
  3. Do not use if labeling is incomplete or illegible.
  4. No component of the Lotus Introducer Set should be resterilized.
  5. Do not insert or remove device if resistance is noted.
  6. Do not attempt advancement without a guidewire. Severe vascular damage and/or injury may occur.
  7. When puncturing, suturing or incising the tissue near the LOTUS Introducer Set, use caution to avoid damaging the Lotus Introducer Set.

POTENTIAL ADVERSE EVENTS:

Potential adverse events include but are not limited to:

  • Air embolism
  • Hemorrhage
  • Infection
  • Injury to the vascular introduction site
  • Procedural discomfort
  • Thromboembolism
  • Thrombosis
  • Tissue trauma
  • Vessel perforation or dissection

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

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